Quest to offer cholesterol testing without fasting requirement

Bill Berkrot

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Sept 7 (Reuters) - Quest Diagnostics Inc said on Thursday it will begin using a more precise method of calculating levels of “bad” LDL cholesterol that no longer requires fasting prior to blood draw, a development likely to delight patients who previously had to refrain from eating for up to 12 hours before testing.

High LDL levels are a key marker of heart disease, with the testing used to determine whether patients should be taking statins, such as Lipitor, or other cholesterol-lowering medications to help prevent heart attacks and strokes. With the current formula for calculating LDL in use since 1972, failure to fast can lead to inaccurate results.

Cholesterol testing is also used to determine if heart patients are achieving LDL target levels, such as under 70 for those deemed at high-risk or under 100 for those at more moderate risk.

In a recent study published in the Journal of Clinical Lipidology, researches said the current calculation method “may lead to the misclassification of high-risk individuals and subsequent under-utilization of lipid-lowering therapies.”

The new LDL calculation method may be especially helpful in following people eligible for potent new injectable PCSK9 cholesterol drugs sold by Amgen Inc or Regeneron Pharmaceuticals Inc and partner Sanofi SA. The old formula was not designed to assess the unprecedented low LDL levels those medicines can now get patients down to.

Being able to eat before testing is almost sure to increase patient compliance.

“Fasting for eight to 12 hours before visiting a patient service center for a blood draw in the morning is challenging and may deter many patients from participating in lipid testing,” Quest Chief Medical Officer Jay Wohlgemuth said in a statement.

Cost and insurance coverage are unaffected by the change, Quest said.

Quest will use the new calculation method at its 2,200 patient service centers under a license agreement with Johns Hopkins University. The formula was developed by Hopkins cardiologist Dr. Seth Martin.

“It’s amazing that since 1972 this had never been updated or changed,” Martin said in an interview, calling it “extremely gratifying” to see his method widely implemented.

The new calculation method was determined using massive amounts of data and modern computing power that were not available to the National Institutes of Health when the cholesterol testing formula was developed 45 years ago, Martin said.

Cholesterol testing is among the top 10 most commonly ordered test services Quest provides each year, the company said. (Reporting by Bill Berkrot in New York; Editing by Lisa Shumaker)